SAN FRANCISCO, June 12, 2025 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced that it will implement a 1-for-25 reverse stock split of its issued and outstanding common stock ("Reverse Stock Split"), effective at 5:00 p.m. Eastern Time on June 16, 2025. FibroGen’s common stock will begin trading on a split-adjusted basis on June 17, 2025, when the markets open, under the Company’s existing trading symbol “FGEN,” with the new CUSIP number 31572Q881. The Reverse Stock Split was previously app ...

SAN FRANCISCO, June 09, 2025 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced the appointment of Dr. Michael Kauffman to its Board of Directors effective June 4, 2025. “Michael is a well-recognized biotech industry veteran, who brings a wealth of biotech leadership experience to our board,” said James Schoeneck, chairman of the board of directors of FibroGen. “His expertise spanning all stages of drug development will be invaluable as FibroGen progresses its pipeline. Michael’s deep underst ...

FibroGen Reports First Quarter 2025 Financial Results May 12, 2025 Forward-Looking Statements This presentation contains contains forward-looking statements regarding FibroGen's strategy, future plans and prospects, including statements regarding its commercial products and clinical programs and those of its collaboration partners Fortis and UCSF. These forward- looking statements include, but are not limited to, statements regarding the efficacy, safety, and potential clinical or commercial success of Fibr ...

Company Performance - FibroGen reported a quarterly loss of $0.16 per share, significantly worse than the Zacks Consensus Estimate of $0.03, representing an earnings surprise of -633.33% [1] - The company posted revenues of $2.74 million for the quarter ended March 2025, exceeding the Zacks Consensus Estimate by 71.19%, but down from $55.9 million in the same quarter last year [2] - Over the last four quarters, FibroGen has surpassed consensus EPS estimates two times and topped consensus revenue estimates three times [2] Stock Movement and Outlook - FibroGen shares have declined approximately 41.8% since the beginning of the year, compared to a -3.8% decline in the S&P 500 [3] - The company's earnings outlook will be crucial for future stock performance, with current consensus EPS estimates at -$0.09 for the coming quarter and -$0.60 for the current fiscal year [4][7] - The current estimate revisions trend for FibroGen is mixed, resulting in a Zacks Rank 3 (Hold), indicating expected performance in line with the market [6] Industry Context - The Medical - Drugs industry, to which FibroGen belongs, is currently ranked in the top 27% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which could impact FibroGen's stock performance [5]

FibroGen (FGEN) Q1 2025 Earnings Call May 12, 2025 05:00 PM ET Company Participants Joanne Greller - Managing Director, IR CommunicationsThane Wettig - CEO & DirectorDavid DeLucia - CFOMatthew Keller - Equity Research Associate Conference Call Participants Andy Hsieh - Research Analyst, Healthcare Operator Please be advised today's conference is being recorded. I would now like to hand the conference over to your speaker today, Joanne Greller. Please go ahead. Joanne Greller Thank you, operator. Good aftern ...

Financial Data and Key Metrics Changes - For Q1 2025, total revenue was $2.7 million, a significant decrease from $25.4 million in Q1 2024 [27] - Total operating costs and expenses for Q1 2025 were $17.7 million, down 76% year-over-year from $74.5 million in Q1 2024 [28] - The net loss from continuing operations for Q1 2025 was $16.8 million, or $0.16 per share, compared to a net loss of $49 million, or $0.49 per share, in Q1 2024 [28] Business Line Data and Key Metrics Changes - The company is focused on advancing FG3246 and FG3180 in metastatic castration-resistant prostate cancer (mCRPC) [6] - Roxadustat is being developed for anemia associated with lower-risk myelodysplastic syndromes (MDS), with a Type C meeting request filed with the FDA [8][23] Market Data and Key Metrics Changes - There are approximately 290,000 men diagnosed with prostate cancer annually in the U.S., with 65,000 being drug-treatable patients in the mCRPC stage [9] - The total addressable market for FG3246 in mCRPC is estimated to exceed $5 billion in annual sales [10] Company Strategy and Development Direction - The company is divesting FibroGen China to AstraZeneca, with total consideration expected to increase to approximately $185 million, extending the cash runway into the second half of 2027 [5][26] - The strategic focus is on U.S. pipeline opportunities, particularly FG3246 and FG3180, and advancing clinical trials [4][6] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the refined focus and multiple near-term catalysts across clinical programs to create shareholder value [9] - The company anticipates important feedback from the FDA regarding roxadustat and plans to initiate the Phase II monotherapy study for FG3246 and FG3180 in mCRPC [31] Other Important Information - The company recorded cash flow positive results in Q1 2025, generating $7.3 million in cash flow on a consolidated basis [29] - The IND for FG3180 was cleared, allowing it to be used alongside FG3246 in upcoming trials [7][12] Q&A Session Summary Question: Regarding clinical development on FG3246 and market dynamics after Pluvicto approval - Management confirmed that Pluvicto experienced patients will be allowed in the Phase II monotherapy trial to mitigate enrollment challenges [38][39] Question: Comments on recent FDA communications regarding roxadustat - Management reported favorable interactions with the FDA, including timely responses to IND filings and Type C meeting requests [40][42] Question: Feasibility studies in colorectal cancer due to cash infusion from AstraZeneca - Management indicated that while colorectal cancer is a potential opportunity, the immediate focus is on starting the Phase II monotherapy trial [44][45]

Financial Performance - For the three months ended March 31, 2025, revenue was $2.739 million, a significant decrease from $25.364 million in the same period of 2024[132]. - Operating costs and expenses for the same period were $17.659 million, down from $74.546 million year-over-year, primarily due to cost control measures and the termination of certain agreements[132][133]. - The loss from continuing operations for Q1 2025 was $16.766 million, or $0.16 per share, compared to a loss of $49.046 million, or $0.49 per share, in Q1 2024[134]. - For the three months ended March 31, 2025, total revenue decreased by $22.6 million, or 89%, to $2.7 million compared to $25.4 million in the same period in 2024[190]. - Drug product revenue, net, fell by $21.9 million, or 89%, to $2.6 million for the three months ended March 31, 2025, primarily due to the termination of the AstraZeneca U.S./RoW Agreement[191]. - Research and development expenses decreased by $27.3 million, or 75%, to $9.2 million for the three months ended March 31, 2025, reflecting cost reduction efforts[202]. - Operating costs and expenses decreased by $56.9 million, or 76%, to $17.7 million for the three months ended March 31, 2025, compared to $74.5 million in the same period in 2024[198]. - Interest income and other income (expenses), net decreased by $1.8 million, or 82%, compared to the same period a year ago, primarily due to lower interest income[208]. - Loss from continuing operations before income taxes was $16.8 million for the three months ended March 31, 2025, compared to a loss of $49.0 million for the same period in 2024[211]. - Cash and cash equivalents totaled $33.609 million as of March 31, 2025, down from $50.482 million at the end of 2024[132]. - Cash and cash equivalents decreased to $33.6 million as of March 31, 2025, from $50.5 million as of December 31, 2024[219]. - Net cash provided by operating activities was $2.7 million for the three months ended March 31, 2025, compared to a net cash used of $59.3 million for the same period in 2024[222][224]. - The company anticipates continued losses despite expected revenue increases from commercial sales of roxadustat in China, Japan, and Europe[230]. - There is substantial doubt about the company's ability to continue as a going concern within 12 months if additional funding is not secured[231]. Development and Clinical Trials - FibroGen is developing FG-3246, a potential first-in-class ADC targeting CD46, with a Phase 2 study expected to begin in Q3 2025 for metastatic castration-resistant prostate cancer (mCRPC)[129][143]. - The company anticipates feedback from the FDA regarding the development plan for roxadustat in lower-risk MDS in Q3 2025[131]. - A share purchase agreement with AstraZeneca is set to close in Q3 2025, involving the sale of FibroGen International and its roxadustat assets in China[129]. - The confirmed objective response rate for FG-3246 in a Phase 1 study was 20%, with a median duration of response of 7.5 months[146]. - The disease control rate for FG-3246 was 80%, with 48% of patients exceeding 24 weeks of treatment[146]. - The combination treatment of FG-3246 with enzalutamide demonstrated a median radiographic progression-free survival (rPFS) of 10.2 months in a Phase 1b/2 study[147]. - The maximally tolerated dose of FG-3246 was established at 2.1 mg/kg adjusted body weight, combined with enzalutamide 160 mg/day[147]. - In the Phase 2/3 MATTERHORN trial, 47.5% of patients in the roxadustat arm achieved transfusion independence for 56 consecutive days, compared to 33.3% in the placebo arm[157]. - A post-hoc analysis showed that 36.1% of roxadustat patients with a higher transfusion burden achieved transfusion independence, versus 11.5% in the placebo group (p=0.047)[157]. - FibroGen plans to file a Type-C meeting request with the FDA regarding roxadustat for anemia associated with lower-risk MDS in Q2 2025, expecting feedback in Q3 2025[158]. Collaborations and Agreements - The company entered into a Share Purchase Agreement with AstraZeneca for approximately $185 million, including $85 million in cash and an additional cash amount of approximately $100 million[160]. - The collaboration with Astellas and AstraZeneca is crucial for the development and commercialization of roxadustat, with total consideration received through March 31, 2025, amounting to $790.1 million[175]. - FibroGen terminated the AstraZeneca U.S./RoW Agreement, effective February 25, 2024, returning all non-China roxadustat rights except for South Korea, with total consideration received of $439.0 million[179]. - The AstraZeneca China Agreement remains unaffected, with total consideration received through March 31, 2025, amounting to $81.2 million[180]. - The company entered into a Share Purchase Agreement with AstraZeneca to sell all equity interests of FibroGen International, expected to close in Q3 2025[213]. Financial Position and Liabilities - As of March 31, 2025, the company had $73.4 million in senior secured term loan facilities, with $10.5 million in interest expected to be paid within the next 12 months[233]. - The company has $61.0 million in liabilities related to the sale of future revenues, with a potential payment cap of $125.0 million anticipated by 2031[234]. - Total non-cancelable purchase obligations amounted to $2.3 million for general purchases, $0.7 million for roxadustat manufacturing, and $0.3 million for FG-3246 manufacturing[232]. - The company has established a full valuation allowance against its net deferred tax assets due to cumulative net losses since inception[212]. - The company may issue and sell shares of common stock having an aggregate offering price of up to $30.0 million under an Equity Distribution Agreement with BofA Securities[218]. Operational Changes and Cost Management - Employee-related costs decreased by $7.8 million due to a reduction in force action and cost control efforts[203]. - Clinical trials costs decreased by $6.9 million primarily due to the termination of pamrevlumab programs in response to clinical data results[203]. - SG&A expenses decreased by $8.6 million, or 52%, for the three months ended March 31, 2025, compared to the same period a year ago[204]. - Cost of goods sold dropped by $21.1 million, or 99%, to $252,000 for the three months ended March 31, 2025, due to the cumulative catch-up adjustment related to the AstraZeneca agreement[199]. - Inventory decreased by $2.9 million due to lower production in China after decommissioning the API manufacturing facility[229]. - Accounts receivable increased by $24.7 million, primarily driven by a $26.0 million receivable from AstraZeneca related to past transactions[229]. - Deferred revenue decreased by $10.2 million, with $5.7 million reclassified to accrued liabilities due to changes in estimated variable consideration[229]. - Accrued interest expense related to the sale of future revenues decreased by $3.6 million, with $5.7 million interest paid during the quarter[229]. - The company has made four quarterly payments totaling $5.4 million to Fortis for the development of FG-3246, with the last payment of $1.7 million made in Q1 2024[169]. - If the option to acquire Fortis is exercised, the company will pay $80 million and could owe up to $200 million in contingent payments for regulatory approvals[170]. - The preclinical portfolio includes FG-3165 and FG-3175, both targeting immune checkpoints for the treatment of solid tumors[164][166].

Financial Performance - Total revenue from continuing operations for Q1 2025 was $2.7 million, a decrease of 89.3% compared to $25.4 million in Q1 2024[16] - Net loss from continuing operations for Q1 2025 was $16.8 million, or $0.16 per share, compared to a net loss of $49.0 million, or $0.49 per share, in the same period last year[16] - Total operating costs and expenses for Q1 2025 were $17.7 million, down from $74.5 million in Q1 2024[20] - The company reported a net income of $4.6 million from discontinued operations in Q1 2025, compared to a net loss of $32.9 million in the same period last year[20] Strategic Transactions - The sale of FibroGen China to AstraZeneca is expected to total approximately $185 million, with net cash held in China at closing estimated to be around $100 million[6] - Upon closing of the sale of FibroGen China, the company's cash runway is extended into the second half of 2027[6] Clinical Development - The initiation of the Phase 2 monotherapy trial of FG-3246 in mCRPC is anticipated in Q3 2025[6] - Topline results from the Phase 2 portion of the investigator-sponsored study of FG-3246 in combination with enzalutamide are expected in Q4 2025[6] - A Type-C meeting request has been filed with the FDA for roxadustat in the treatment of anemia associated with LR-MDS, with feedback expected in Q3 2025[8] Cash Position - Cash, cash equivalents, and accounts receivable totaled $128.4 million as of March 31, 2025[16]

Core Insights - FibroGen reported financial results for Q1 2025, highlighting a significant decrease in total revenue compared to the same period in 2024, with total revenue of $2.7 million versus $25.4 million [14] - The company is focused on advancing its lead asset, FG-3246, with a Phase 2 monotherapy dose optimization study expected to start in Q3 2025 [2][5] - FibroGen is in the process of selling its China operations to AstraZeneca for approximately $185 million, which is expected to close in Q3 2025 [5][6] Financial Performance - Total revenue for Q1 2025 was $2.7 million, a decrease from $25.4 million in Q1 2024 [14] - The net loss from continuing operations for Q1 2025 was $16.8 million, or $0.16 per share, compared to a net loss of $49.0 million, or $0.49 per share, in the previous year [14][19] - As of March 31, 2025, FibroGen reported $33.8 million in cash and cash equivalents in the U.S. and $128.4 million in total consolidated cash [14] Strategic Developments - The company has filed a Type C meeting request with the FDA to discuss the potential Phase 3 development program for roxadustat in treating anemia associated with lower-risk myelodysplastic syndromes (LR-MDS) [2][7] - The anticipated initiation of the Phase 2 monotherapy trial of FG-3246 in metastatic castration-resistant prostate cancer (mCRPC) is set for Q3 2025 [5][11] - Topline results from the Phase 2 portion of the investigator-sponsored study of FG-3246 in combination with enzalutamide are expected in Q4 2025 [5][6] Transaction Details - The sale of FibroGen China to AstraZeneca is expected to provide a total consideration of approximately $185 million, which includes an enterprise value of $85 million plus estimated net cash of $100 million [5][6] - Upon closing, the transaction will extend FibroGen's cash runway into the second half of 2027 [5][14] Upcoming Milestones - The company anticipates feedback from the FDA regarding the development plan for roxadustat in Q3 2025 [7] - The Phase 2 trial of FG-3246 will also include FG-3180 to assess its diagnostic performance and correlation with CD46 expression [6][11]

Core Insights - The report titled "Duchenne Muscular Dystrophy - Pipeline Insight, 2025" provides a comprehensive overview of the current landscape of Duchenne Muscular Dystrophy (DMD) therapies, focusing on over 75 companies and pipeline drugs [1][2] Pipeline Overview - The report includes detailed profiles of pipeline drugs, covering both clinical and nonclinical stages, and assesses therapeutics by product type, stage, route of administration, and molecule type [2][10] - Approximately 75+ key companies are involved in developing therapies for DMD, with Roche having candidates in the most advanced stage, i.e., Phase III [7] Emerging Drugs - Vamorolone, developed by Santhera, is a first-in-class drug candidate that aims to dissociate efficacy from typical steroid safety concerns, addressing the unmet medical need in DMD patients [4] - Givinostat, an HDAC inhibitor from Italfarmaco, targets pathogenetic events downstream of genetic defects, potentially benefiting the entire DMD and BMD population [5] - Pamrevlumab, developed by FibroGen, is a first-in-class antibody that inhibits connective tissue growth factor (CTGF) and is currently in Phase 2 trials for DMD [6] Therapeutic Assessment - The report categorizes DMD drugs based on various parameters, including route of administration and molecule type, providing insights into the therapeutic landscape [10][11] - The pipeline includes drugs at different phases of clinical development: late-stage (Phase III), mid-stage (Phase II), early-stage (Phase I), as well as preclinical and discovery stage candidates [8] Development Activities - The report highlights collaborations, acquisitions, mergers, and licensing activities related to DMD therapeutics, indicating a dynamic development environment [12] - Key players in the industry include Santhera Pharmaceuticals, Sarepta Therapeutics, Italfarmaco, Wave Life Sciences Ltd., and FibroGen, among others [15][18]